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Dorzolamide/timolol combination versus concomitant administration of brimonidine and timolol: six-month comparison of efficacy and tolerability.
Ophthalmology. 2003 Mar; 110(3):615-24.O

Abstract

PURPOSE

To compare the efficacy and tolerability of the 2% dorzolamide/0.5% timolol combination ophthalmic solution twice daily to the concomitant administration of 0.2% brimonidine ophthalmic solution twice daily and 0.5% timolol ophthalmic solution twice daily.

DESIGN

Randomized, multicenter, observer-masked, parallel-group study.

PARTICIPANTS

Two hundred ninety-three patients with ocular hypertension or primary open-angle glaucoma participated.

INTERVENTION

After an open-label 3-week 0.5% timolol run-in period, patients with an hour 2 intraocular pressure (IOP) of > or = 22 mmHg were randomly assigned to receive either the dorzolamide/timolol combination twice daily or the concomitant use of brimonidine twice daily and timolol twice daily (brimonidine + timolol) for 6 months.

MAIN OUTCOME MEASURES

The IOP-lowering effects at hour 0 and hour 2 were collected at 1, 3, and 6 months. We hypothesized that both treatment regimens would have comparable hour 2 IOP-lowering effects at month 3. The treatments were considered comparable if the two-sided 95% confidence interval of the treatment difference was within +/- 1.5 mmHg. Tolerability data were also collected at 1, 3, and 6 months.

RESULTS

The primary efficacy analysis was based on the modified intent-to-treat population. At month 3, hour 2, the dorzolamide/timolol group had an adjusted mean (standard error) change in IOP of -5.04 (0.30) mmHg versus -5.41 (0.30) mmHg in the brimonidine + timolol group, with a treatment difference of 0.36 (0.40) mmHg (95% confidence interval [CI] of -0.42-1.14 mmHg). At month 3, hour 0, the dorzolamide/timolol group had a change in IOP of -3.66 (0.29) mmHg versus -4.15 (0.28) mmHg in the brimonidine + timolol group, with a treatment difference of 0.49 (0.39) mmHg (95% CI of -0.27-1.25 mmHg). Likewise, at all other observed time points, the 95% confidence interval of the treatment difference was within +/- 1.5 mmHg. Ninety-three patients (64%) in the dorzolamide/timolol group and 88 patients (60%) in the brimonidine + timolol group had adverse experiences that were deemed drug related by the investigator, for which 7 patients (5%) in the dorzolamide/timolol group and 8 patients (5%) in the brimonidine + timolol group were discontinued from the study.

CONCLUSIONS

The efficacy of the dorzolamide/timolol combination and the concomitant administration of brimonidine and timolol were comparable. The incidence of drug-related adverse experiences and the incidence of discontinuations caused by drug-related adverse experiences were similar between groups.

Authors+Show Affiliations

Sall Eye Surgery Medical Center Inc., Bellflower, California, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

12623832

Citation

Sall, Kenneth N., et al. "Dorzolamide/timolol Combination Versus Concomitant Administration of Brimonidine and Timolol: Six-month Comparison of Efficacy and Tolerability." Ophthalmology, vol. 110, no. 3, 2003, pp. 615-24.
Sall KN, Greff LJ, Johnson-Pratt LR, et al. Dorzolamide/timolol combination versus concomitant administration of brimonidine and timolol: six-month comparison of efficacy and tolerability. Ophthalmology. 2003;110(3):615-24.
Sall, K. N., Greff, L. J., Johnson-Pratt, L. R., DeLucca, P. T., Polis, A. B., Kolodny, A. H., Fletcher, C. A., Cassel, D. A., Boyle, D. R., & Skobieranda, F. (2003). Dorzolamide/timolol combination versus concomitant administration of brimonidine and timolol: six-month comparison of efficacy and tolerability. Ophthalmology, 110(3), 615-24.
Sall KN, et al. Dorzolamide/timolol Combination Versus Concomitant Administration of Brimonidine and Timolol: Six-month Comparison of Efficacy and Tolerability. Ophthalmology. 2003;110(3):615-24. PubMed PMID: 12623832.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Dorzolamide/timolol combination versus concomitant administration of brimonidine and timolol: six-month comparison of efficacy and tolerability. AU - Sall,Kenneth N, AU - Greff,Linda J, AU - Johnson-Pratt,Lisa R, AU - DeLucca,Paul T, AU - Polis,Adam B, AU - Kolodny,Andrea H, AU - Fletcher,Charlena A, AU - Cassel,Deborah A, AU - Boyle,Denise R, AU - Skobieranda,Franck, PY - 2003/3/8/pubmed PY - 2003/3/26/medline PY - 2003/3/8/entrez SP - 615 EP - 24 JF - Ophthalmology JO - Ophthalmology VL - 110 IS - 3 N2 - PURPOSE: To compare the efficacy and tolerability of the 2% dorzolamide/0.5% timolol combination ophthalmic solution twice daily to the concomitant administration of 0.2% brimonidine ophthalmic solution twice daily and 0.5% timolol ophthalmic solution twice daily. DESIGN: Randomized, multicenter, observer-masked, parallel-group study. PARTICIPANTS: Two hundred ninety-three patients with ocular hypertension or primary open-angle glaucoma participated. INTERVENTION: After an open-label 3-week 0.5% timolol run-in period, patients with an hour 2 intraocular pressure (IOP) of > or = 22 mmHg were randomly assigned to receive either the dorzolamide/timolol combination twice daily or the concomitant use of brimonidine twice daily and timolol twice daily (brimonidine + timolol) for 6 months. MAIN OUTCOME MEASURES: The IOP-lowering effects at hour 0 and hour 2 were collected at 1, 3, and 6 months. We hypothesized that both treatment regimens would have comparable hour 2 IOP-lowering effects at month 3. The treatments were considered comparable if the two-sided 95% confidence interval of the treatment difference was within +/- 1.5 mmHg. Tolerability data were also collected at 1, 3, and 6 months. RESULTS: The primary efficacy analysis was based on the modified intent-to-treat population. At month 3, hour 2, the dorzolamide/timolol group had an adjusted mean (standard error) change in IOP of -5.04 (0.30) mmHg versus -5.41 (0.30) mmHg in the brimonidine + timolol group, with a treatment difference of 0.36 (0.40) mmHg (95% confidence interval [CI] of -0.42-1.14 mmHg). At month 3, hour 0, the dorzolamide/timolol group had a change in IOP of -3.66 (0.29) mmHg versus -4.15 (0.28) mmHg in the brimonidine + timolol group, with a treatment difference of 0.49 (0.39) mmHg (95% CI of -0.27-1.25 mmHg). Likewise, at all other observed time points, the 95% confidence interval of the treatment difference was within +/- 1.5 mmHg. Ninety-three patients (64%) in the dorzolamide/timolol group and 88 patients (60%) in the brimonidine + timolol group had adverse experiences that were deemed drug related by the investigator, for which 7 patients (5%) in the dorzolamide/timolol group and 8 patients (5%) in the brimonidine + timolol group were discontinued from the study. CONCLUSIONS: The efficacy of the dorzolamide/timolol combination and the concomitant administration of brimonidine and timolol were comparable. The incidence of drug-related adverse experiences and the incidence of discontinuations caused by drug-related adverse experiences were similar between groups. SN - 0161-6420 UR - https://www.unboundmedicine.com/medline/citation/12623832/Dorzolamide/timolol_combination_versus_concomitant_administration_of_brimonidine_and_timolol:_six_month_comparison_of_efficacy_and_tolerability_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(02)01900-0 DB - PRIME DP - Unbound Medicine ER -